3 Division of Gastroenterology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.

4 AbbVie AB, Solna, Sweden.

5 AbbVie Spain S.L.U., Madrid, Spain.

6 AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.

7 AbbVie Inc., North Chicago, Illinois, USA.

8 Academic Medical Center, Amsterdam, Netherlands.

Abstract

BACKGROUND: PYRAMID was an international multicenter, noninterventional, postmarketing registry assessing long-term safety and effectiveness of adalimumab (Humira), as used in routine clinical practice.

METHODS: Adult patients with moderately to severely active Crohn's disease with or without prior adalimumab experience were enrolled in the registry and followed for up to 6 years. Effectiveness measurements included the Physician's Global Assessment (PGA, a composite of Harvey Bradshaw Index [HBI] and rectal bleeding score), clinical remission (HBI < 5), Short InflammatoryBowel Disease Questionnaire (SIBDQ), and Work Productivity and Activity Impairment (WPAI) questionnaire. Data were reported for adalimumab-naïve patients and analyzed by baseline immunomodulator use and disease duration.

RESULTS: This study evaluated 2057 adalimumab-naïve patients. Mean PGA improved from 7.5 (baseline) to 3.9 (year 1) and 3.3 (year 6). The proportion of patients in HBI remission increased from 29% (573 of 1969; baseline) to 68% (900 of 1331; year 1) and 75% (625 of 831; year 6). Patients stratified by baseline immunomodulator use had similar HBI remission rates; patients with diseaseduration <2 years achieved numerically higher HBI remission rates than patients with longer disease duration. Patient-reported SIBDQ and WPAI scores improved at year 1; all WPAI subscore improvements were clinically meaningful (≥7% point change) at year 1 and maintained through year 6. Serious infections were reported in 11.1% of patients; incidence rates of malignancies, lymphoma, and demyelinating disorders were low.

CONCLUSION: Adalimumab therapy, as used in routine clinical practice, improved physician-reported and patient-reported diseaseoutcomes and remission rates for up to 6 years. No new safety signals were observed.